FDA continues to cite manufacturers with serious Design Control violations found during inspections which lead to Warning Letters. Very recently a company received a Warning Letter that includes significant design...

The updated “EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices” standard was published August 30, 2012 in the Official Journal as harmonized to the Medical Device Directive, Active...

Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions - Risk Management is becoming an integral part of the compliance process. There...